AccessGUDID - DEVICE: Blood - Urine Speciment Convenience Kit (00859952006116)

GUDID

Device Identifier (DI) Information

Brand Name: Blood - Urine Speciment Convenience Kit
Version or Model: SA93010
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SA93010
Company Name: CAPITOL VIAL, INC.

Primary DI Number: 00859952006116
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 151639481 *Terms of Use

Device Description: Blood - Urine Specimen Convenience Kit

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47591	Evacuated blood collection tube IVD, anticoagulant/antiglycolytic	A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, an anticoagulant [e.g., ethylenediaminetetraacetic acid (EDTA), ammonium oxalate, potassium oxalate, sodium heparin, sodium citrate], and an antiglycolytic agent (e.g., sodium fluoride, lithium iodoacetate). It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., blood glucose or lactate determinations). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ed8fdf4a-96bf-4379-a6ee-aebb1b366379
Public Version Date: August 23, 2023
Public Version Number: 4
DI Record Publish Date: August 25, 2017